NCT03347552

Brief Summary

The purpose of this project is to investigate the effectiveness of the Home-Based Mental Health Evaluation (HOME) program, which is an innovative and culturally-relevant suicide prevention intervention for Veterans aimed at increasing treatment engagement and decreasing suicide risk following psychiatric hospitalization, a period of heightened suicide risk.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
323

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 29, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 20, 2017

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

2.3 years

First QC Date

November 15, 2017

Last Update Submit

April 13, 2018

Conditions

Keywords

treatment engagement

Outcome Measures

Primary Outcomes (2)

  • Treatment Engagement 1

    Access to participants' VA electronic medical record will be utilized to address the hypothesis that Veterans participating in the HOME program will be significantly more likely to engage in treatment and or care more quickly. Data collection may be facilitated by VA's Compensation and Pension Record Interchange (CAPRI) and VA's Corporate Data Warehouse (CDW).

    From discharge from the hospital through 90 days post discharge

  • Treatment Engagement 3

    Access to participants' VA electronic medical record will be utilized to address the hypothesis that Veterans participating in the HOME program will be significantly more likely to attend more outpatient appointments. Data collection may be facilitated by VA's Compensation and Pension Record Interchange (CAPRI) and VA's Corporate Data Warehouse (CDW).

    From discharge from the hospital through 90 days post discharge

Secondary Outcomes (1)

  • Lower Suicidal Ideation scores

    3 months post-discharge

Study Arms (2)

Active Treatment

EXPERIMENTAL

Participants in the active arm will be enrolled in the HOME Program.

Behavioral: HOME

E-CARE

NO INTERVENTION

Receiving enhanced care as usual. Participants at these sites are described as receiving "enhanced care as usual" or "E-CARE" because they will be recruited, enrolled and complete baseline and follow-up assessments in addition to care as usual.

Interventions

HOMEBEHAVIORAL

Prior to discharge from the inpatient unit, the HOME program provider or another member of the research team, will meet individually with the Veteran to provide further information regarding the HOME program intervention. Efforts are made to schedule the initial phone call and home visit that occur during the first week after discharge. Following the home visit, the HOME provider may continue to have weekly contact with the Veteran via the telephone or in person until he or she is disenrolled following engagement in outpatient care. "Engaged in care" is defined as attendance at two individual outpatient mental health appointments or engagement in equivalent or elevated care as determined by the PI. All clinical contacts with the Veteran may include the following: suicide risk assessment, review and modification of the Veteran's safety plan, review and modification of the discharge plan, involvement of the Veteran's support system, and facilitation of engagement in outpatient care.

Active Treatment

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18-89
  • Able to provide a phone number and the location of a residence at which they can be reached
  • Planned location of discharge is a safe environment for the HOME provider to visit\*
  • Agree to receive the HOME program intervention (active site participants only)
  • Ability to adequately respond to questions regarding the informed consent procedure

You may not qualify if:

  • Receiving services from the Mental Health Intensive Case Management (MHICM) or Domiciliary program or being directly transferred to further inpatient or residential treatment
  • Enrolled in other intervention studies that may affect the outcome of this study, or where this study may affect the outcome of the other study, until the subject has completed their participation in the other study
  • Current involvement in the criminal justice system as a prisoner or ward of the state.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

VA Portland Health Care System

Portland, Oregon, 97239, United States

Location

Philadelphia VA Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Matarazzo BB, Gerard GR, Jankovsky MC, Oslin DW, Brenner LA. Feasibility and Acceptability of the HOME Program for Veterans Recently Discharged from a Psychiatric Hospitalization. Adm Policy Ment Health. 2021 Nov;48(6):974-982. doi: 10.1007/s10488-021-01109-7. Epub 2021 Feb 1.

MeSH Terms

Conditions

SuicideSelf-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Bridget B Matarazzo, PsyD

    VA Rocky Mountain MIRECC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The blind assessor will administer follow up measures. In order to keep the assessor blind to participant status (active vs. control), research staff will facilitate phone calls. To monitor blinding, the blind assessor will record if participants inadvertently un-blind themselves during the assessment and also record their guess to which treatment condition (active versus E-CARE)participants were allocated.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2017

First Posted

November 20, 2017

Study Start

April 29, 2014

Primary Completion

September 1, 2016

Study Completion

November 30, 2016

Last Updated

April 17, 2018

Record last verified: 2018-04

Locations